Monday, August 24, 2009

No FDA Regulations Would Be Like Driving on a Highway Without Speed Limits

“What If There Were No Rules?', asks Richman. "There’s no FDA, no DDMAC, no FTC. Your company guidelines and rules don’t exist and your regulatory and legal teams have been disbanded. It’s a free-for-all and there are no rules. The question is: what would you do?"

He includes a nice survey of readers that I encourage you to respond to. But before you do that, have a look at my own parallel survey that may encourage you to think about an analogy to the real world: What if there were no laws against speeding?

3 comments:

Thanks for the link, John, even if it appears you're comparing my post to a horrible car wreck. I'll take what I can get. ; )

I'll be interested to see if people get the point of my post, which is quite simple: Even if there were no rules, you'd be forced to essentially do the same things. Doctors wouldn't fall for exaggerated claims and patients will reject all of our outreach via social media unless it's valuable.

So, the question is: are the rules holding you back or is something else?

Trusting physicians/marketing managers to allow market forces to play out, in the US market, is like saying we should let the Iranians decide if nuclear weapons are needed for the people in their own country? Physicians are for the most part altruistic and understanding business is not their strong point and they have no idea what would happen if pharma ran amock. They buy into science but can also be swayed by pseudo-science that the Big 10 pharma's have been shelling out for the last 3 decades.I could go on for hours on the price-fixing, TV ad marketeers, ghost writers, fake scientific front "associations in the public science" that have been used and quoted to get docs to believe over the years.....The reason that companies send in 6 reps a month on one doc is that they know docs can be swayed by repetition plus the benefit of free lunch for their staff. Who knows what the real costs are in "drug development"? Why? the consumer rarely knows the cost because they paid $0 or a $10 co-pay for 15 years. Now they know because drug profits have increased double digit every year for 2 decades. One year a former company I worked for told the sales staff that the budget had no ceiling and to spend until they said stop. The excess is enormous. Hello? Why was Big Pharma a sure bet in your portfolio for years? No one wanted to look at the excess and no one saw the price going up and out of control. I'm in pharma and I would love to see control. I once watched the Chief of Surgery at one of the Top Med School's veto a $50,000 cost savings on a project because they didn't use that in his Med. School and he wasn't going to learn a new system. No one in the room agreed but he won because he was the top income driver of the facility. Then the next week I watched a chief at a low ranked school argue over purchasing a 0.01 cent increase in the vitamins his facility purchased for the poor, long term he was concerned about the physicians profit sharing.Wall Street would opt for no controls and look how well that affected them last year, and they understand finances.

About the Author

Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own.